The right support starts with a defined scope.

01

Study Feasibility

• Country feasibility
• Institution and investigator identification
• Population and care-pathway assessment
• Operational risk assessment
• Feasibility recommendations

02

Study Start-up

• Start-up planning
• Essential-document collection
• Site qualification
• Site initiation
• Investigator and site training

03

Ethics and Regulatory Coordination

Coordination and submission support only—not approval services.

• Submission-package preparation
• NHRC and institutional ethics coordination
• DDA-related coordination when applicable
• Response and query tracking
• Amendment and continuing-review support

04

Clinical Monitoring

• Qualification visits
• Initiation visits
• Routine monitoring
• Remote monitoring
• Close-out visits
• Protocol-deviation and action-item tracking

05

Site Management

• Site readiness
• Study coordination
• Investigator communication
• Recruitment-planning support
• Document and training oversight
• Issue escalation

06

TMF and Essential Documents

• TMF planning
• Document collection and review
• Filing-quality checks
• Completeness tracking
• Inspection-readiness support

07

Medical Device Research

• Device feasibility
• Site and user readiness
• Device accountability
• IFU and protocol-compliance monitoring
• Imaging and procedure-workflow support
• Clinical investigation support when required by the sponsor’s regulatory strategy

08

Safety and Pharmacovigilance Support

• Safety-information coordination
• SAE documentation support
• Reporting-timeline tracking
• Site safety communication
• Escalation support

09

Study Close-out

• Close-out preparation
• Essential-document reconciliation
• Outstanding-action resolution
• Investigational product or device reconciliation
• Record-retention planning